Biomarker Challenges: Spiked Quality Controls, Can They Bias your Results?

Quality controls (QCs) are an inherent part of every ligand binding assay (LBA), as they help monitor within-run and between-run precision and relative accuracy. QCs are also critical to ensuring that an LBA yields reproducible results over time, as supported by several publications and regulatory guidances. QCs can take different forms, such as neat or diluted biological matrices (Matrix QCs) and recombinant biomarkers diluted in matrix or surrogate matrix (Spiked QCs). While it is widely acknowledged that matrix QCs better reflect assay performance compared to their spiked counterparts, the impact of relying solely on spiked QCs to assess precision and accuracy remains less understood. Although most scientists strive to include matrix QCs in their methods, they sometimes use only one (e.g a low QC), with mid and high QCs being spiked, or they may rely entirely on spiked QCs due to the low endogenous concentration of their biomarkers of interest.

During this Rapid Fire presentation, assay performance tracking using different types of QCs such as matrix QCs, recombinant proteins spiked into surrogate matrix, and spiked QCs prepared in matrix will be showcased. The potential negative impact on sample results when relying on spiked QCs will also be discussed using case studies. This presentation will emphasize the importance of using matrix QCs to monitor each level of an LBA standard curve and the possible consequences that spiked QCs may have on study data.